This research project will collect and analyze qualitative and quantitative data about US biobanks, exploring how organizational strategies, features, and attributes affect both framing and response to ELSI and policy choices. We argue that a biobank's organizational features impact 1) policy choices directly, and 2) members'framing and response to ELSI which in turn impact policy choices. We will select 12 biobanks with diverse creation strategies (creating collections from the "ground up" (de novo), repurposing non-research collections, and networking existing specimen collections) for exploratory in-depth case studies of their history, evolution, and response to ELSI and policy choices. Using the results of the case studies, we will refine questions and hypotheses about the relationships between organizational strategies, features, and attributes, ELSI, and policy choices in order to inform a survey of 500 biobank administrators selected from a systematic sampling frame. As a follow-up to the survey, interviews with 50 administrators who reported different policy choices in key areas will be conducted to further explore our findings. Based on data from these two AIMS, we will present policy recommendations to a group of biobank stakeholders, and using a Delphi process, we will develop consensus about guidelines to present to policy makers and the US biobank community. PUBLIC HEALTH RELEVANCE: This is a study of organizations, called "biobanks," that collect, store, manage, and share human samples, such as blood or tissue, for the purpose of conducting health research. Because this is a new and rapidly evolving industry, it is important to understand how biobanks respond to ethical, legal, and policy concerns that arise from genetic research that relies upon such long term storage and use. We will interview people who work in these organizations about their experiences, in order to make recommendations about the best ways to resolve these concerns.